Kornimate/medical-research-clean huggingface dataset:
peripheral neuropathy in colorectal cancer patients under adjuvant chemotherapy with folfox, flox or xelox regime

Conditions: Colorectal Cancer

Summary: oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. it is used combined with fluorouracil (5 fu) and leucovorin. the main and most suffering side effect of oxaliplatin is polyneuropathy. oxaliplatin-induced polyneuropathy (oipn) can be acute and/or chronic neurotoxicity. the early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. it has been used different neurotoxicity scales in grading oipn. in this study the investigators try to investigate whether the evaluation of the vibrotactile perception vtp, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying oipn in patients undergoing adjuvant chemotherapy treatment with folfox, flox or xelox regime.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed written informed consent. * fulfils the indication of the treatment with 3-6 months oxaliplatin combined adjuvant chemotherapy. * polyneuropathy grade according to ctcae before treatment start ≤ 2. * performance status according to who ≤ 1. exclusion criteria: * age \< 18 years. * the patient does not consent to the examination * polyneuropathy grade according to ctcae before treatment start \>2. * performance status according to who \>1.

Keywords: polyneuropathy oxaliplatin colorectal cancer
evaluating the safety and performance of the minilung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure

Conditions: Extracorporeal Membrane Oxygenation Complication; Neonatal Aspiration Pneumonia; Acute Respiratory Failure; Acute Lung Injury

Summary: this prospective observational study will evaluate the safety and performance of the minilung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure. the main question it aims to answer is (study hypotheses): veno-venous (vv) and veno-arterial (va) extracorporeal membrane oxygenation (ecmo) using the minilung petite kit is safe and improves gas exchange (oxygenation and co2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and/or cardiopulmonary failure within 24 hours compared to the treatment before vv or va ecmo initiation and maintain a life-sustaining condition.


Eligibility criteria:
inclusion criteria * informed consent signed and dated by parents or legal representative and investigator/authorized physician * patients ≥2- ≤8 kg bodyweight to be treated with the minilung petite kit * acute severe respiratory and/or cardiopulmonary failure with an ecmo indication exclusion criteria: * participation in an interventional clinical study during the preceding 30 days that could interfere with the ecls therapy * previous participation in the same study * prematurity (\<34 weeks gestational age) * hypersensitivity to heparin or known history of heparin induced thrombocytopenia (hit) * impossibility of systemic anticoagulation

Keywords: extracorporeal membrane oxygenation neonatal and pediatric patients minilung petite kit
examining cognitive mechanisms of clinical improvement following mindfulness based therapy for depressed individuals

Conditions: Depression

Summary: depression one of the leading causes of disability worldwide. individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly referred to as "cognitive flexibility"). mindfulness meditation training is a technique which involves focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. it has been well documented to improve depressive symptoms and prevent recurrence of depressive episodes, yet little is known about how mindfulness does so and what are the underlying mental mechanisms involved. here the investigators propose to examine the efficacy of an 8-week mindfulness training program in improving the ability to direct and control attention, as well as in cognitive flexibility. individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training program. participants' depressive symptoms as well as their performance on measures of attention and cognitive flexibility will be examined. participants will be assigned to mindfulness training or a wait-list control group. half of the participants will be examined before and after the mindfulness training program and the other half will be tested 8-weeks apart and then begin their training.


Eligibility criteria:
inclusion criteria: * reporting dysphoria for at least two months prior * ham-d score of at least 11 * no history of psychiatric disorders of psychotic features, neurological disorders, or substance abuse in the past 6 months * verified age between 18-65 years old * had no suicidal attempts during the past six months * no prior experience with mbct or other systematic meditation programs exclusion criteria: * history of psychosis, neurological disorder, and substance abuse for the past 6 months * suicide attempt in past 6 months * prior experience with mbct or other systematic meditation program
right ventricular function and exercise capacity in patients with continuous-flow left ventricular assist devices

Conditions: Heart Failure

Summary: exercise capacity in continous-flow left ventricular assist device (cf-lvad) patients remains severely reduced post-implant. while the effect of right ventricular (rv) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late rv failure on exercise capacity and quality of life (qol) has been sparsely described. thus the purpose of this study is to examine rv function and the association to exercise capacity in cf-lvad patients.

when pharmacological therapy becomes insufficient in advanced end-stage heart failure (hf) transplantation remains the gold standard of therapies. however, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. mechanical circulatory support in the form of a cf-lvad is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. implantation with a cf-lvad increases survival and improves quality of life, but peak oxygen uptake (peak vo2) remains severely reduced post-implant. complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. furthermore a fixed cf-lvad pump speed prevents adequate circulatory support during strenuous exercise. the effects of late right ventricular (rv) failure on exercise capacity and quality of life (qol) is, however, unknown and the purpose of this study is to examine rv function and the association to exercise capacity in cf-lvad patients.

Eligibility criteria:
inclusion criteria: * outpatients from department of cardiology, rigshospitalet, denmark. * age ≥ 18 years. * ischemic or non-ischemic cardiomyopathy. * signed informed consent. exclusion criteria: * unstable patients with the need for intravenous inotropic therapy. * cf-lvad implantation less than one month ago. * egfr \< 45 ml/min. * contrast allergy.
observational study of cortical spreading depression in human brain trauma

Conditions: Traumatic Brain Injury

Summary: since the primary damage from traumatic brain injury (tbi) is irreversible, the focus of medical management of tbi is preventing secondary injury that can be life-threatening and worsen patient outcome. insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments. in preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of tbi patients in the first week after injury. spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. animal research has shown that spreading depressions can cause secondary injury to the brain. the primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from tbi. results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the tbi patient.


Eligibility criteria:
inclusion criteria: * 18-80 years old * diagnosis of tbi * craniotomy performed as per required treatment of tbi * craniotomy surgery \< 7 days after tbi * gcs\<13 at time of decision for surgery * expected neuromonitoring for \>72 hr exclusion criteria: * any failure to meet above criteria * pregnancy * gcs 3 with fixed, dilated pupils

Keywords: spreading cortical depression electroencephalography traumatic brain injury intensive care vascular hypotension intracranial hypertension
cognitive and neurological pathologies in pompe disease

Conditions: Pompe Disease

Summary: the purpose of this study is to better understand the long-term health effects of pompe disease and to determine if there are any abnormal changes in the brain and peripheral nerves. additionally, the investigators will study the relationship between the abnormal changes in brain, nervous system findings, and developmental outcomes. the investigators will collect clinical information from clinic visits as well as assessments such as neuroimaging (magnetic resonance imaging (mri), magnetic resonance spectroscopy (mrs), and diffusion tensor imaging (dti)), cognition, academic skills, speech and language function, physical therapy and quantitative muscle ultrasound. subjects will be in this study for at least 3 years and up to 6 years.


Eligibility criteria:
inclusion criteria: * subject has a confirmed and documented diagnosis of infantile pompe disease (ipd) or late onset pompe disease (lopd) exclusion criteria: * refusal to give informed consent
clinical trial assessing the value of an antibiotic protocol guided by serum procalcitonin in acute exacerbations of chronic obstructive pulmonary disease in intensive care

Conditions: Chronic Obstructive Pulmonary Disease

Summary: investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (pct) on morbidity and mortality in patients with chronic obstructive pulmonary disease (copd) hospitalized in intensive care unit (icu) for acute exacerbation with or without associated pneumonia. the main objective is to show in patients hospitalized in intensive care for acute exacerbation of copd with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the pct in the icu.


Eligibility criteria:
inclusion criteria: * patients over 18 years * documented or suspected clinically copd according to the criteria of gold * in acute exacerbation * suspect of lower respiratory tract infection * with or without pulmonary criteria defined as the presence of a radiological infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° c, fireplace clinical auscultation, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³ * admitted to the hospital for less than 48 hours * icu admission * informed consent signed by the patient or his representative exclusion criteria: * other than acute exacerbation etiology with or without pulmonary disease as suspected cause of icu admission * patient immunocompromised neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, hiv seropositivity * severe acute asthma * moribund patient or a disease with an estimated survival time of less than three months * therapeutic limitation existence * minor patient or under guardianship or custody * pregnant woman * refusal to participate in the study * the inclusion of the subject in another biomedical research protocol in progress or for less than 30 days
the effects of dexmedetomidine on early stage renal functions in pediatric patients

Conditions: Renal Function Disorder; Hemodynamic Instability

Summary: the aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage renal function.

background: contrast-induced nephropathy is the third most common cause of acute renal failure in hospitalized patients in all age groups. in this study we aimed to investigate the effects of dexmedetomidine on early stage renal function in pediatric patients undergoing cardiac angiography. methods: 60 pediatric patients between 6 and 72 months of age undergoing cardiac angiography were included in the study. patients were divided into two groups. the patients in both groups were administered 1mgkg-1 ketamine, 1mgkg-1 propofol as bolus and followed by 1 mgkg-1hour-1 ketamine and 50 µgkg-1min-1 propofol infusion. additionally, a loading dose of 1 µgkg-1 dexmedetomidine given over 10 minutes followed by 0.5 µgkg-1hour-1 dexmedetomidine infusion to patients in group d. the patients were evaluated for ngal, creatinine, renin, endothelin-1, tas and tos blood levels before the procedure and 6th and 24th hours after the procedure. prifle criteria were used to define cin and its incidence in the study.

Eligibility criteria:
inclusion criteria: * 6 and 72 months children * scheduled for cardiac angiography exclusion criteria: * patients with renal failure or diabetes mellitus, patients who were on nephrotoxic and vasoactive drugs simultaneously, patients with decompensated congestive heart failure and patients who had been administered contrast media in the last two weeks

Keywords: contrast-induced nephropathy, dexmedetomidine, endothelin-1
analgesic efficacy after umbilical hernia repair in children

Conditions: Umbilical Hernia

Summary: umbilical hernia repair is a common painful outpatient procedure performed in children. often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and nsaids both iv and orally. the use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. the rectus sheath block can be performed in these patients to decrease their post operative pain.

umbilical hernia repair, a common day surgery procedure in children, is associated with considerable postoperative discomfort. the patient has to meet certain discharge criteria such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from the day surgery unit. currently, both rectus sheath block and local infiltration of the surgical site are used for providing post-operative analgesia for umbilical hernia repair surgery. the local infiltration can only be done at the end of the surgical procedure as it could alter the planes of the surgical field if performed preoperatively. we believe that the analgesia provided prior to the surgical incision will decrease the amount of intraoperative and postoperative opioids used and the subsequent side effects of these medications (5,6). the rectus sheath block, a regional anesthetic technique, offers possible improved pain management following umbilical hernia repair in a recent observational study (1-3,7). we will perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and surgical infiltration in providing postoperative analgesia.

Eligibility criteria:
inclusion criteria: 1. male or female subjects ages \> 5 to \< 18 years. 2. american society of anesthesiology (asa)physical status 1 or 2. 3. patients who undergo an umbilical hernia repair at chop. exclusion criteria: 1. parents/patients refusal to the placement of a rectus sheath nerve block. 2. subjects with allergy to bupivacaine. 3. patients who are developmentally delayed which precludes their participation in pain scale reporting. 4. parents who do not comprehend english sufficiently well to read the consent and ask questions.

Keywords: rectus sheath local infiltration pain control
post market observational, prospective, multi-center study

Conditions: Emphysema

Summary: this registry is a post market observational, prospective, multi-center registry. it is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this ce mark product.


Eligibility criteria:
inclusion and exclusion criteria in the registry are based on ce mark approved indication and approved instructions for use. patients enrolled and treated in the registry study should meet the requirements of the pneumrx endobronchial coil system instructions for use.

Keywords: coil repneu pneumrx lvrc
parents as the primary sexuality educators for their young adults with down syndrome

Conditions: Down Syndrome; Intellectual Disability; Sexuality; Parent-Child Relations

Summary: by integrating sexuality and disability literatures, theories, and research methodologies, this study aims to: 1) contribute to the limited knowledge professionals have of parents as the primary sexuality educators; 2) create a resource for parents in order to be sexuality educators for their young adults with i/dd; and 3) evaluate the effectiveness of the home b.a.s.e. for developmental disabilities curriculum. in order to meet the objectives the study seeks to answer the following questions: 1. what is the effectiveness of a sexuality education workshop for parents of young adults with ds on improving the self-efficacy and attitudes around sexuality and healthy relationships for young adults with ds as well as increase the parent-child communication on sexuality topics? 2. what are parents' concerns that impact their ability to be the primary sexuality educators for their young adults with ds? it is proposed that parent confidence and comfort talking about sexuality topics with their young adult with down syndrome will increase thereby increasing the parent-child communication as a result of this study.

enrollment will begin and will end once 30 eligible subjects have been identified. anticipated duration is one year. participants will enroll in one of the 4 different training series. each series will have 3 dates they must attend. once enrolled and consent is documented, eligible subject's will participate in the study for approximately three months. participants will be expected to attend 3 training sessions over a 4 week period, each are up to 3 hours in length. there will be a follow-up post-survey one month after the last training and an optional phone interview that will occur 2 months after the final training. participants will be compensated for their time with a $50 gift card once the final post-survey has been received. the gift card will be mailed to the family. data analysis will begin once all trainings have been completed. investigators anticipate completing the study, including primary analyses, within two years from the date recruitment begins.

Eligibility criteria:
inclusion criteria: * parents of young adults with down syndrome ages 20-30. * be able to communicate in english exclusion criteria: * parents of young adults between the ages of 20 and 30 without down syndrome * parents of individuals with down syndrome younger than 20 or older than 30. * parents unable to attend 3 training sessions. * not fluent english communicators. * any vulnerable populations including pregnant women, neonates, prisoners, children, cognitively impaired adults, or adults unable to consent

Keywords: parent training family education young adults down syndrome sexuality
a study of xeloda (capecitabine) in combination with chemotherapy in patients with advanced and/or metastatic gastric cancer.

Conditions: Gastric Cancer

Summary: this study will assess the safety and efficacy of xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. all patients will receive xeloda in combination with one of 4 standard chemotherapy regimens; the dose of xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * advanced or metastatic gastric cancer; * eastern cooperative oncology group (ecog) \<=2. exclusion criteria: * previous chemotherapy (except adjuvant or neoadjuvant treatment \>=6 months prior to study); * evidence of central nervous system (cns) metastasis; * history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix); * clinically significant cardiac disease.
the safety and effectiveness of clarithromycin in the prevention of mycobacterium avium complex (mac) infection in hiv-infected patients

Conditions: Mycobacterium Avium-intracellular Infection; HIV Infections

Summary: to determine whether clarithromycin is safe and effective in preventing disseminated mycobacterium avium complex in hiv-infected patients with cd4 counts \<= 100 cells/mm3.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection. * cd4 count \<= 100 cells/mm3. * no evidence of mac. * life expectancy of at least 6 months. exclusion criteria concurrent medication: excluded: * certain restricted drugs (details not available). patients with the following prior conditions are excluded: history of allergy or hypersensitivity to macrolides. active substance abuse or other conditions that would affect study compliance.

Keywords: mycobacterium avium-intracellular infection acquired immunodeficiency syndrome clarithromycin
application of sodium bicarbonate ringer's solution in laparoscopic hepatectomy

Conditions: Hepatic Ischemia

Summary: compared the effects of sodium bicarbonate ringer's solution and lactate ringer's solution on the internal environment and hemodynamics of patients during laparoscopic liver resection, to observe the application prospect of sodium bicarbonate ringer's solution in laparoscopic hepatectomy.

the study was a single-center prospective randomized controlled study. a total of 100 patients undergoing laparoscopic hepatectomy under general anesthesia were randomly divided into 2 groups: group a, sodium bicarbonate ringer's solution group(n=50); group b, lactate ringer's solution group (intraoperative crystal fluid dilatation was lactate ringer's injection, n=50); collect patients' arterial blood gas, blood pressure, heart rate, peripheral vascular resistance, heart rate, blood vessels, the active drug usage, 5% sodium bicarbonate injection usage, inflammation factors, transaminase, creatinine, etc. with the point of preoperative (t0), during liver specimens resected(t1), after liver specimens resected(t2), and the end of surgery (t3). then statistical analysis and observe the application prospect of sodium bicarbonate ringer's injection in laparoscopic hepatectomy.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old, 2. patients who plan to undergoing laparoscopic hepatectomy ; 3. willing to sign informed consent. exclusion criteria: 1. age \<18 years 2. pregnancy 3. active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) 4. history of significant cerebrovascular disease 5. restrictive or obstructive pulmonary disease 6. uncontrolled hypertension 7. renal dysfunction (glomerular filtration rate \<60 ml/min), 8. evidence of hepatic metabolic disorder (bilirubin \>35 mmol/l) 9. presence of active infection